Development of a Framework for Enhancing the Transparency, Reproducibility and Communication of the Benefit-Risk Balance of Medicines

The current process of benefit–risk assessment of medicines relies primarily on intuitive expert judgment. Frameworks are needed for transparent, rational and defensible decision making that benefits patients, drug developers, and decision makers. The Benefit Risk Action Team framework is a set of p...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2011-02, Vol.89 (2), p.312-315
Main Authors: Coplan, PM, Noel, RA, Levitan, BS, Ferguson, J, Mussen, F
Format: Article
Language:English
Subjects:
Communication
Decision Making
Drug Industry
Drug-Related Side Effects and Adverse Reactions
Product Surveillance, Postmarketing
Reproducibility of Results
Risk Assessment
Statistics as Topic
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Summary:The current process of benefit–risk assessment of medicines relies primarily on intuitive expert judgment. Frameworks are needed for transparent, rational and defensible decision making that benefits patients, drug developers, and decision makers. The Benefit Risk Action Team framework is a set of processes and tools for selecting, organizing, summarizing, and interpreting data that is relevant to decisions based on benefit–risk assessments. It provides a standardized yet flexible platform for incorporating study outcomes and preference weights as well as for communicating the rationales for decisions. Clinical Pharmacology & Therapeutics (2011) 89 2, 312–315. doi:10.1038/clpt.2010.291
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2010.291